Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease

NYU Langone Health

Status: Enrolling

Conditions: Inflammatory Bowel Diseases

Treatments: Other: Nutrition specialist; Dietary Supplement: Ensure Surgery Immunonutrition shakes

Study type: Interventional

Funder types: Other

Identifiers

NCT06309017

23-01243

Details and patient eligibility

About

This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able and willing to provide written informed consent
2. Aged 18 years of age or older
3. Confirmed diagnosis of inflammatory bowel disease
4. Scheduled for disease-related intestinal resection at NYU Langone Health

Exclusion criteria

1. No current diagnosis of inflammatory bowel disease
2. Age less than 18
3. Not proficient (able to read and answer questions) in English

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Nutrition specialist

Experimental group

Description:

Participants will be assigned to this arm if the subject is determined malnourished. They will be sent to a nutrition specialist for a nutrition focused visit and will be provided standard of care intervention prior surgery.

Treatment:

Dietary Supplement: Ensure Surgery Immunonutrition shakes

Other: Nutrition specialist

Standard of Care

Active Comparator group

Description:

Participants that show no signs of malnutrition will be assigned to this arm. The subject will be provided with education and schedule of Ensure® Surgery Immunonutrition shakes for prior to surgery as per standard of care.

Treatment:

Dietary Supplement: Ensure Surgery Immunonutrition shakes